First NSF Lawsuit to Go to Trial in California

One of the first trials involving a gadolinium contrast dye – Magnevist – and nephrogenic systemic fibrosis (NSF) is set to begin in January. According to a report on Law.com, the outcome of the Magnevist trial could be a good indicator of how NSF plaintiffs in similar lawsuits will fare.

Bayer’s Magnevist, as well other gadolinium contrast dyes, including General Electric’s Omniscan and Covidien’s OptiMark, have been named in over 500 lawsuits filed by people who claim they or their loved ones developed NSF following exposure to one or more of the gadolinium-based MRI contrast dyes.

NSF is an often-fatal disease that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness.

There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death. While not much is known about the disease, a growing mountain of evidence indicates that NSF only occurs in people with severe kidney disease who have been exposed to a gadolinium contrast dye.

In 2007, the U.S. Food & Drug Administration (FDA) mandated a black box warning about the risk of NSF for all gadolinium agents. The agency is now considering tougher warnings that could restrict the use of some gadolinium agents to only patients without severe kidney disease, following a risk assessment that found Omniscan, OptiMark and Magnevist appeared to carry a higher risk of NSF than other gadolinium products on the market.

Most NSF lawsuits filed around the country have been consolidated in federal court in the Northern District of Ohio. However, according to Law.com, the Magnevist lawsuit scheduled for trial in January is one of 20 to 30 California NSF lawsuits that have been consolidated before San Francisco Superior Court Judge Richard Kramer. While this suit only names Bayer as a defendant, General Electric is also a major defendant in the California litigation.